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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

STANDARD™ F HbA1c

UDI-DI 08800111725661Basic UDI-DI 88001117IPCA01FA05VX

Class C · IVDR · SD Biosensor Inc.

Identification
Model
F-A1C
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 075369 0075

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-06-25 · Expiry 2031-06-24

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

SD Biosensor Inc.

SRN KR-MF-000009168

KR · Gyeonggi-do, Suwon-si

manufacturer

Authorised representative: Medical Technology Promedt Consulting GmbH (DE-AR-000000085)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/standardtm-f-hba1c-5661 · UDI page: /udi/08800111725661

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